Senior Mechanical Design Engineer

This position is eligible for a $5,000 sign on bonus.

This position is located on-site based out of our corporate headquarters in Brooklyn Park, MN.

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you

You are a part of:

The Engineering team consists of engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

JOB SUMMARY

The Senior Mechanical Design Engineer is primarily responsible for defining, designing, and developing components and assemblies for Class II and Class III medical devices and related accessories. Able to multitask and run multiple projects while meeting customer commitments. This position is responsible for solutions to product design, design for manufacturability, and translating requirements from the customer into realized products. Required are strong analytical skills to understand customer requirements, foresee technical challenges and lead the definition of design solutions to meet customer needs, specifically; manufacturability, cost, quality, reliability, regulatory requirements, effectiveness, and safety. The Senior Mechanical Design Engineer leads the design efforts for small to medium scale programs, can work independently, act as a technical lead, and be a mentor to other engineers on these programs.

ESSENTIAL RESPONSIBILITIES

• Lead the mechanical development of new designs, improve existing designs, and transition current and future designs into production.
• Own the design and development of medical devices through:
o Transformation of internal and external inputs into outputs
o Develop design requirements and specifications with mechanical and electrical components and assemblies.
o Create test methods and corresponding test method validations.
o Lead dFMEA creation.
o Coordinate design verification activities.
o Generate 3D models and engineering drawings utilizing Solidworks.
o Perform tolerance analyses to ensure component interactions are understood.
o Understand the functional performance of the products as they are developed.
o Communicate technical risks as they arise.
• Develop basic data and make preliminary layouts, sketches, and notes necessary to present design proposal.
• Identify design errors, omissions, and other deficiencies, and recommending revisions and/or improvements in design layout to engineers or designers.
• Investigate pertinent design factors such as ease of manufacture, availability of materials and equipment, interchangeability, replace ability, strength-weight efficiency, and contractual specification requirements and cost.
• Check completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and accuracy of calculations and dimensioning.
• Make layouts of assemblies and details parts of devices, mechanisms, structures, and products.
• Host design reviews with internal and external stakeholders.
• Coordinate with other organizations affected by design development.
• Assist, as an available resource, Business Development and Applications Engineering in quoting and proposal development.
• Research, evaluate and recommend equipment, technologies, material, and methodologies that improve quality, reduce costs and decrease program development time.
• Serve as technical expert in phase or design reviews with internal and external stakeholders.
• Evaluate feasibility of concepts and provides estimates for mechanical design timelines.
• Manage workload to support various projects, in small to medium scale and complexity.
• Mentorship of other engineers in various functions.
• Maintain compliance to procedures and regulatory requirements.
• Provides regular status updates to management and or customer.
• Writes/updates work instructions, part specifications, verification protocols, and various technical documents.
• Other duties as assigned.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this position.

QUALIFICATIONS

• A Bachelor’s degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
• Minimum of 5 years of experience
• Experience and knowledge working under quality management systems that meet governmental regulations such as FDA QSR, ISO 13485, the MDD relevant standards, and have knowledge cGMP, GDP principles and practices.
• Experience implementing Design for Manufacturability (DFM) principles into design.
• Proficiency with CAD required, Solidworks preferred.
• Knowledge of dimensioning and tolerances, GD&T.
• Understands tolerance stack ups and properly design alignment for assemblies.
• Good understanding of the product development process within the medical device industry.
• Able to multitask and support multiple projects while meeting customer commitments.
• Computer skills associated with Microsoft software.
• Must be able to read, write and speak fluent English.
• Excellent reading, writing, communication, and organizational skills.
• Possess team collaboration skills.
• Strong mechanical aptitude.
• Strong desire to mentor and spread knowledge.

WHAT WE OFFER

• A fast-paced work environment
• Paid time off
• 401(k) retirement savings with a company match
• Clean, and well-lit production areas
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.